NBIH¿ TEMPORARY PACING ELECTRODE CATHETER

Description of Event or Problem

IT WAS REPORTED THAT THE INTERVENTIONAL CARDIOLOGIST WAS NOT ABLE TO NAVIGATE THE TEMPORARY PACING ELECTRODE LEAD IN RIGHT VENTRICLE OF THE PATIENT.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. THE DHR REVIEW COULD NOT BE COMPLETED BECAUSE THE PROVIDED LOT NUMBER WAS INVALID. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: PRECAUTIONS: EXCESSIVE BENDING, TORQUING, OR KINKING OF THE ELECTRODE CATHETER MAY CAUSE DAMAGE TO THE CATHETER INCLUDING DAMAGE TO INTERNAL WIRES. WHEN USING A BALLOON CATHETER, USE CARE WHEN REMOVING THE PROTECTIVE SLEEVE FROM THE DISTAL PORTION OF THE CATHETER. FORCED REMOVAL OF THIS PROTECTIVE SLEEVE MAY RESULT IN DAMAGE TO THE BALLOON AND THE CATHETERS STRUCTURAL INTEGRITY. WHEN WIPING DOWN THIS CATHETER, USE ONLY STERILE SALINE. WARNINGS: GENERAL WARNINGS, THE RISKS OF USING TEMPORARY PACING CATHETERS INCLUDE THOSE RISKS RELATED TO HEART CATHETERIZATION, SUCH AS THROMBOEMBOLISM, PERFORATION, TAMPONADE, AND INFECTION. THE INDUCTION OF AN UNINTENDED ARRHYTHMIA IS A KNOWN COMPLICATION. ELECTRICAL CONNECTIONS FOR PACING: 2. THREAD LEADS OF CATHETER THROUGH THE ADAPTER EYELET. CONNECT THE NEGATIVE JACK (MARKED DISTAL) TO THE NEGATIVE TERMINAL OF THE EXTERNAL PULSE GENERATOR, AND THE POSITIVE JACK (UNMARKED) TO THE POSITIVE TERMINAL OF THE PULSE GENERATOR. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THE INTERVENTIONAL CARDIOLOGIST WAS NOT ABLE TO NAVIGATE THE TEMPORARY PACING ELECTRODE LEAD IN RIGHT VENTRICLE OF THE PATIENT.